Tech , Quality Assurance

Job Description

This position supports production at a medical device manufacturer. The role requires working in a controlled environment with appropriate gowning and personal protective equipment (PPE) such as hair net, beard cover (if applicable), safety glasses, shoes, hearing protection and smock. It involves significant walking and standing. The technician must detect visual defects—surface irregularities, color variations, and dimensional inconsistencies—whether or not a reasonable accommodation is requested.

Technology requirements include basic computer skills in Outlook, Microsoft Word, and Excel. Preferred: SAP.

Preferred background:
Prior quality assurance experience in the medical device or pharmaceutical industry. Priority soft skills:
Good communication skills.

A typical day focuses on supporting production and maintaining product quality. Responsibilities include responding to line nonconformances, assisting production with appropriate actions, containing defects to isolate and control affected products, and guiding documentation of nonconformances. The technician performs spot checks on the production floor to verify adherence to procedures, maintains GMP compliance by checking cleanliness, organization and labeling, and performs other quality-related tasks as needed.

• Provide training and feedback to operations staff to support skill development and compliance with quality standards.
• Promote a culture of quality, safety, and continuous improvement within the team.
• Monitor inspection processes and ensure adherence to SOPs, work instructions, and quality standards.
• Conduct daily audits of production areas and documentation to ensure compliance and identify improvement opportunities.
• Maintain accurate and timely documentation of inspections, audits, and quality events.
• Support preparation for internal and external audits.
• Identify and recommend improvements to inspection methods, tools, and documentation practices.
• Assist departments in containment and segregation of nonconforming product/materials and ensure proper documentation and escalation.
• Confirm defects of nonconforming product/materials found in production.
• Assist in root‑cause investigations and corrective action implementation for deviations and nonconformances.
• Collaborate with operations and engineering to resolve quality issues and improve inspection processes.
• Communicate effectively with cross‑functional teams to support production goals and quality initiatives.
• Participate in quality improvement projects.
• Ensure compliance with all applicable safety regulations, including RCRA hazardous waste handling, and company policies.
• Perform other duties as assigned.

• This position includes frequent work in a cleanroom or laboratory manufacturing environment and the physical demands described are representative of those that must be met by an incumbent to successfully perform the essential functions of this job.
• This position also includes frequent work in an office environment which requires use of a computer and its accessories.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990).
• The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequently required. The employee is regularly exposed to episodes of walking, kneeling, balancing, crouching, pushing/pulling, repetitive grasping, hearing, twisting, lifting, frequent use of hand and fingers.
• The position will almost always have exposure to work near moving mechanical equipment and potential temperature fluctuations.
• Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
• The incumbent may be exposed to noise levels in the work environment moderate to loud.
• The incumbent must be willing and able to wear the required PPE such as safety glasses, face mask and/or shield, hearing protection, safety shoes, smock, hairnet, and beard covering.